Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study

This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

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Key information

Conditions

Hematologic Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

About this study

These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the "Instructions for Use".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all clinic attendees

Exclusion criteria

unable to provide a venous and fingerstick blood specimen

Treatment and study plan

iMOST X-1 Hematology Analyzer

Diagnostic Test

The X-1 is a point of care automated hematology analyzer

Primary outcomes

Method Comparison of CBC Results

Time frame: October- December 2020

Blood Diagnostic Tests for CBC

Sponsors and collaborators

Lead sponsor

Essenlix Corporation

Industry

Registry information

Official study title

Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Mar 3, 2021
Registry last updated: Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed